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Nutritional Prevention Pilot Trial for Type 1 Diabetes (MIP)

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
European Union
Juvenile Diabetes Research Foundation
Diabetes Research Foundation, Finland
Novo Nordisk A/S
Information provided by (Responsible Party):
Mikael Knip, Helsinki University
ClinicalTrials.gov Identifier:
NCT00570102
First received: December 7, 2007
Last updated: November 27, 2012
Last verified: November 2012

December 7, 2007
November 27, 2012
February 1995
March 2004   (final data collection date for primary outcome measure)
Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00570102 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nutritional Prevention Pilot Trial for Type 1 Diabetes
Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study

The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

Among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. Among the latter cow's milk proteins are of special interest. They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. In humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer.

This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula .

This project is a pilot multicenter trial comprising 15 hospitals in Finland.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Type 1 Diabetes Mellitus
  • Dietary Supplement: A highly hydrolyzed formula
    Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months
  • Dietary Supplement: A regular cow's milk based formula
    Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin
  • Active Comparator: A highly hydrolyzed casein formula
    Intervention: Dietary Supplement: A highly hydrolyzed formula
  • Placebo Comparator: A conventiona cow's milk based formula
    Intervention: Dietary Supplement: A regular cow's milk based formula

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
January 2008
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • the participant must have a mother, biological father or sibling with type 1 diabetes
  • the participant must carry a susceptible HLA genotype(HLA-DQB1*02 and/or DQB1*0302 without protective alleles (DQB1*0301, *0602 and *0603)

Exclusion Criteria:

  • no telephone
  • no accessibility to any of the research centers
  • inability of parents to understand the study and instructions
  • unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
  • gestational age less than 36 weeks
  • Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
  • the newborn infant has received any cow's milk-based product prior to randomization
Both
up to 7 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00570102
195003, BHM4-CT96-0233
No
Mikael Knip, Helsinki University
Helsinki University
  • Academy of Finland
  • European Union
  • Juvenile Diabetes Research Foundation
  • Diabetes Research Foundation, Finland
  • Novo Nordisk A/S
Principal Investigator: Hans K Åkerlom, MD, PhD University of Helsinki, Helsinki, Finland
Helsinki University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP